Gas-elimination patient access device

ABSTRACT

Disclosed are devices, systems, and methods for providing access to a patient. The patient access device comprises a proximal end, a distal end and a lumen therethrough. The patient access device further comprises a hollow shaft, an input port and a liquid supply port. At least a portion of the lumen passes through the shaft. The input port is coupled to the lumen, and the lumen and the input port are constructed and arranged to receive an elongate probe. The liquid supply port is in fluid communication with the lumen. The patient access is constructed and arranged to reduce gas from exiting the distal end while a portion of the elongate probe is positioned in the patient access device.

RELATED APPLICATIONS

The present application claims priority under 35 USC 119(e) to U.S.Provisional Patent Application Ser. No. 61/928,704, entitled“Gas-Elimination Patent Access Device,” filed Jan. 17, 2014, which isincorporated herein by reference in its entirety.

FIELD

The present invention is generally related to patient access devices andmethods that facilitate the insertion of percutaneous devices into apatient's vascular system or other body lumen, and more particularly, topatient access devices and methods configured to reduce the chance ofair or other gas bubbles entering the patient's vascular system during apercutaneous procedure.

BACKGROUND

During many percutaneous procedures, medical devices are inserted into apatient's vascular system and advanced through blood vessels to reach adesired location. Small amounts of air or other gas bubbles can beaccidentally introduced into the vascular system during the procedure.For example, gas bubbles can enter the bloodstream as a catheter orother medical device is advanced through a patient access device, suchas a vascular introducer sheath, resulting in gas bubbles (i.e. gasemboli) in the bloodstream. Gas bubbles that enter a vein can becaptured or otherwise stopped within the lungs. However, if a gas bubbleor collection of gas bubbles in the venous system is sufficiently largeand becomes trapped in a chamber of the heart, blood flow in the heartcan become compromised and can result in serious injury and even death.

One or more gas emboli within an artery, termed arterial gas embolism(AGE), often lead to more serious consequences than gas bubbles in avein, such as when a gas bubble in an artery stops blood flow to atissue area fed by the artery. The consequences of ‘AGE’ depend on thearea deprived of blood flow, and can include stroke, if the brain isaffected, or a heart attack, if the heart is affected.

Typically, patient access devices, such as vascular introducer sheaths,are used during clinical therapeutic and diagnostic procedures tofacilitate insertion and exchange of catheters or other medical devicesinto a patients' vascular system. The introducer sheaths are tubesinserted into patients' vascular systems to act as guides for thecatheters or other medical devices. Once the distal end of theintroducer sheath is inserted into a patients' vascular system, theproximal end of the sheath remains outside the patient for theintroduction of catheters or other medical devices.

When a catheter or other medical device is inserted into the proximalend of the sheath, air or other gas may be carried into the sheath withthe catheter or other medical device, and passed into the patients'vascular system. As discussed above, this gas may form gas emboli whenentering the blood stream, preventing normal blood flow to the heart,brain or other body location, and potentially causing tissue damage oreven death of the patient. If a first device needs to be replaced with asecond device, the first device is withdrawn from the sheath and thesecond device is then inserted into the sheath, including an additionalrisk of introducing gas into the patient's vascular system. If thedevices used in treating the patient must be exchanged frequently viathe sheath, the chance of gas introduction into the patients' vascularsystem is further increased.

Since typical introducer sheaths and other patient access devices do notprevent introduction of gas into the patient's bloodstream along withthe catheter or other medical device being inserted, clinicians arerequired to manually prevent such an occurrence. Therefore, there is aneed for improved patient access devices and methods of deviceintroduction to prevent or reduce the introduction of gas bubbles intothe patient's bloodstream to avoid the complications discussed above.

SUMMARY

In accordance with aspects of the present invention, a patient accessdevice comprises a proximal end, a distal end, and a lumen therethrough.The device further comprises a hollow shaft, and at least a portion ofthe lumen passes through the shaft. The device further comprises aninput port coupled to the lumen, and the lumen and the input port areconstructed and arranged to receive an elongate probe. The devicefurther comprises a liquid supply port in fluid communication with thelumen, and the patient access device is constructed and arranged toreduce gas from exiting the distal end while a portion of the elongateprobe is positioned in the patient access device.

In some embodiments, the patient access device further comprises atleast one valve assembly configured to restrict flow between the lumenand an inserted elongate probe. The shaft can comprise a proximalportion and one valve assembly can be positioned on the shaft proximalportion. The shaft can comprise a proximal end and one valve assemblycan be attached to the shaft proximal end. The shaft can comprise adistal portion and one valve assembly can be positioned on the shaftdistal portion. The one valve assembly can comprise a compressible ringand a compressing collar. The shaft can comprise a thin portion and thevalve assembly can be positioned on the shaft thin portion.

In some embodiments, the patient access device further comprises a firstvalve assembly and a second valve assembly. The first valve assembly canbe constructed and arranged to allow flow through the lumen at a firstpressure and the second valve assembly can be constructed and arrangedto allow flow through the lumen at a second pressure, the secondpressure being higher than the first pressure. The first valve assemblycan be proximal to the second valve assembly. The patient access devicecan be constructed and arranged such that when the pressure within thelumen is between the first pressure and the second pressure, fluidpasses through the first valve assembly.

In some embodiments, the patient access device is coupled with a patientintroducer assembly. The patient introducer assembly can comprise avascular introducer.

In some embodiments, the patient access device further comprises aconduit. The conduit can be constructed and arranged to bepercutaneously inserted into a blood vessel of the patient.

In some embodiments, the patient access device is constructed of one ormore biocompatible materials. The biocompatible materials can comprise amaterial selected from the group consisting of: metal; stainless steel;a cobalt alloy; Ni—Ti alloy; titanium alloy; ceramic; plastic; apolymer; polyethylene; polyvinylchloride; polyurethane; polylactide; aflexible material; silicone; latex; and/or combinations and/orsub-combinations thereof.

In some embodiments, the shaft comprises a rigid portion and a flexibleportion. The patient access device can further comprise a valve assemblysurrounding the flexible portion.

In some embodiments, the shaft comprises a transparent portion.

In some embodiments, the input port comprises a valve assembly. Thevalve assembly can comprise a Tuohy-borst valve assembly.

In some embodiments, the liquid supply port comprises a first fluid portand the patient access device further comprises a second fluid port. Thesecond fluid port can comprise a second liquid supply port. The secondfluid port can comprise a fluid output port. The patient access devicecan further comprise a pump fluidly connected to the liquid supply portand the fluid output port. The shaft can comprise a proximal portion anda distal portion and the liquid supply port can be in fluidcommunication with the shaft proximal portion and the second fluid portcan be in fluid communication with the shaft distal portion.

In some embodiments, the elongate probe comprises a catheter. Theelongate probe can comprise an expandable array. The expandable arraycan comprise a spiral. The expandable array can comprise a basketconstruction. The expandable array can comprise an array of transducers.The expandable array can comprise an array of sensors. The expandablearray can comprise an array of electrodes.

In some embodiments, the liquid supply port is positioned on a proximalportion of the shaft.

In some embodiments, the liquid supply port is positioned on a distalportion of the shaft.

In some embodiments, the liquid supply port comprises a luer.

In some embodiments, the patient access device further comprises a tubefluidly connected to the shaft and the liquid supply port. The tube cancomprise a flexible tube. The liquid supply port can comprise a luerfluidly attached to the tube.

In some embodiments, the patient access device further comprises a fluiddelivery assembly configured to deliver fluid to the lumen of the shaft.The fluid delivery assembly can be configured to flush fluid over atleast a portion of the elongate probe to perform a function selectedfrom the group consisting of one or more of: prevent gas from enteringthe lumen; drive gas to exit the proximal end of the patient accessdevice; and/or combinations and/or sub-combinations thereof. The fluiddelivery assembly can be constructed and arranged to deliver acontinuous supply of fluid to the lumen. The fluid delivery assembly cancomprise a control configured to allow an operator to initiate thedelivery of the fluid. The control can comprise a stopcock. The controlcan comprise a roller valve. The control can comprise a buttonconfigured to be pressed to initiate a flow of fluid. The fluid deliveryassembly can comprise a sensor configured to detect insertion of theelongate probe into the input port and the fluid delivery assembly canbe configured to automatically deliver fluid based on one or moresignals produced by the sensor. The fluid delivery assembly can comprisea gravity-fed source of fluid. The fluid delivery assembly can comprisea pump. The fluid delivery assembly can comprise one or more controlsconfigured to allow an operator to perform a function selected from thegroup consisting of one or more of: initiate flow of fluid; increaserate of flow of fluid; decrease rate of flow of fluid; set the volume ofthe flow of fluid; and/or combinations and/or sub-combinations thereof.

In some embodiments, the patient access device further comprises asensor configured to detect insertion of the elongate probe into acomponent selected from the group consisting of one or more of: theinput port; the lumen; and/or combinations and/or sub-combinationsthereof. The patient access device can be configured to automaticallyinitiate the flow of fluid through the lumen based on the detection ofthe elongate probe by the sensor.

In some embodiments, the patient access device further comprises a flowsensor configured to produce a signal based on fluid flowing through thelumen. The flow sensor can be configured to detect the presence of fluidflow through the lumen. The flow sensor can be configured to detectfluid flow rate through the lumen. The patient access device can beconstructed and arranged to maintain a flow rate above 1 ml/min flowingthrough the lumen. The flow sensor can be configured to produce a signalcorresponding to the volume of fluid flowing through the lumen.

In some embodiments, the patient access device further comprises a gasbubble detector. The gas bubble detector can be configured to detect agas bubble in the lumen. The shaft can comprise a distal portion and thegas bubble detector can be positioned to detect a gas bubble in theshaft distal portion. The gas bubble detector can comprise an ultrasoundgas bubble detector.

In some embodiments, the patient access device further comprises a powersupply. The power supply can comprise a battery.

In some embodiments, the patient access device further comprises analarm transducer. The alarm transducer can comprise an audio transducer.The patient access device can be configured to activate the alarmtransducer when a condition is detected, the condition selected from thegroup consisting of one or more of: absence of flow; flow rate below athreshold; presence of a gas bubble; advancement of elongate probe;and/or combinations and/or sub-combinations thereof.

In some embodiments, the patient access device further comprises a gasdisrupting component positioned within the lumen. The gas disruptingcomponent can comprise a component selected from the group consisting ofone or more of: a wiper; a brush; and/or combinations and/orsub-combinations thereof.

In some embodiments, the patient access device further comprises asecond fluid pathway intersecting the lumen. The second fluid pathwaycan be constructed and arranged to receive fluid via at least one ofmanual feed such as with a syringe or automatic feed such as with apump.

In some embodiments, the patient access device further comprises avibrating element constructed and arranged to disrupt gas bubbles. Thevibrating element can be constructed and arranged to vibrate the shaftand physically disrupt air bubbles on the elongate probe.

In some embodiments, the portions of the shaft comprise a transparentcompliant material constructed and arranged to allow a user to manuallymassage out visible gas bubbles within the lumen. The patient accessdevice can further comprise a support element within the compliantportion of the shaft.

According to another aspect of the present invention, a patient accessdevice comprises a proximal end, a distal end, and a lumen therethrough.The device further comprises a hollow shaft, and at least a portion ofthe lumen passes through the shaft. The device further comprises aninput port constructed and arranged to receive an elongate probe. Thedevice further comprises a liquid supply port in fluid communicationwith the lumen, and the patient access device is constructed andarranged to prevent gas from passing from the proximal end to the distalend as the elongate probe is advanced through the lumen.

According to another aspect of the present invention, a method of usinga patient access device comprises inserting an elongate probe into alumen at a proximal end of the patient access device. The method furthercomprises flowing fluid into the lumen through a liquid supply port influid communication with the lumen. The method further comprisesflushing fluid over at least a portion of the elongate probe while it ispositioned in the lumen to perform a function selected from the groupconsisting of one or more of: reduce gas from entering the lumen; drivegas toward a proximal end of the patient access device; and/orcombinations and/or sub-combinations thereof.

In some embodiments, the method further comprises closing a valveassembly positioned on a distal portion of the patient access deviceprior to flowing the fluid into the lumen.

In some embodiments, the method further comprises coupling a patientintroducer assembly to a distal end of the patient access device. Themethod can further comprise percutaneously inserting the patientintroducer assembly into a blood vessel of a patient.

In some embodiments, the liquid supply port is positioned on a proximalportion of the patient access device.

In some embodiments, the liquid supply port is positioned on a distalportion of the patient access device.

In some embodiments, the method further comprises detecting theinsertion of the elongate probe into the input port with a sensor andthe fluid delivery assembly is configured to automatically deliver fluidbased on one or more signals produced by the sensor.

In some embodiments, the method further comprises detecting a gas bubblein the lumen with a gas bubble detector.

According to another aspect of the present invention, a delivery devicefor delivering an elongate probe into a vascular introducer comprises aproximal end, a distal end and a lumen therethrough. The device furthercomprises a hollow shaft, and at least a portion of the lumen passesthrough the shaft. The device further comprises a funnel shaped inputport constructed and arranged to receive a distal portion of an elongateprobe. The device further comprises a liquid supply port in fluidcommunication with the lumen and the delivery device is configured toperform a function selected from the group consisting of one or more of:remove gas bubbles from the lumen; reduce gas bubbles from exiting thelumen; reduce gas bubbles from entering the lumen; and/or combinationsand/or sub-combinations thereof.

In some embodiments, the funnel shaped input port is constructed andarranged to radially compact an expanded portion of the elongate probe.

In some embodiments, the device further comprises at least one fluiddelivery tube, and the shaft comprises a distal portion and the at leastone fluid delivery tube extends to said shaft distal portion. The atleast one fluid delivery tube can comprise multiple delivery tubes. Theat least one fluid delivery tube can comprise multiple outlet ports influid communication with the lumen. The at least one fluid delivery tubecan be in fluid communication with the liquid supply port. The at leastone fluid delivery tube can comprise an outlet port constructed andarranged such that delivered fluid travels both toward the patientaccess device proximal end and the patient access device distal end.

In some embodiments, the liquid supply port comprises a luer.

In some embodiments, the liquid supply port comprises a shutoff valve.

According to another aspect of the present invention, provided is apatient access device as shown in the drawings.

According to another aspect of the present invention, provided is adelivery device configured to deliver an elongate probe into a vascularintroducer as shown in the drawings.

According to another aspect of the present invention, provided is amethod of treating a patient using a patient access device as shown inthe drawings.

According to another aspect of the present invention, provided is amethod of diagnosing a patient using a patient access device as shown inthe drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become more apparent in view of the attacheddrawings and accompanying detailed description. The embodiments depictedtherein are provided by way of example, not by way of limitation,wherein like reference numerals refer to the same or similar elements.The drawings are not necessarily to scale, emphasis instead being placedupon illustrating aspects of the invention.

FIGS. 1A and 1B illustrate one embodiment of a patient access deviceconstructed and arranged to prevent gas from exiting a distal end of alumen of the device while a portion of an elongate medical device orother elongate probe is within the lumen, consistent with aspects of thepresent invention.

FIG. 1C illustrates another embodiment of a patient access deviceconstructed and arranged to prevent gas from exiting a distal end of alumen of the device while a portion of an elongate probe is within thelumen, consistent with aspects of the present invention.

FIGS. 2A-2C illustrate one embodiment of a shaft used in the patientaccess device of FIGS. 1A-1C having both a rigid portion and flexibleportion for forming a valve, consistent with the present invention.

FIG. 3A-3D illustrates one embodiment of the patient access device ofFIGS. 1A-1C with an elongate probe, consistent with aspects of thepresent invention.

FIG. 4 illustrates one embodiment of a “smart” patient access devicehaving additional components to increase the patient access devicecapability, consistent with aspects of the present invention.

FIG. 5 illustrates the use of the patient access device of FIG. 1A, 1Cor 4, consistent with aspects of the present invention.

FIG. 6A illustrates another embodiment of a patient access device havingboth input and output liquid supply ports in an “open” fluid system thatdoes not recirculate the fluid during use, in accordance with aspects ofthe present invention.

FIG. 6B illustrates another embodiment of a patient access device havingboth input and output liquid supply ports in a “closed” fluid systemthat is configured to recirculate the fluid during use, in accordancewith aspects of the present invention.

FIG. 7 illustrates another embodiment of a patient access device havingan input port with funnel shaped assembly and least one fluid deliverytube within a lumen of the patient access device, consistent withaspects of the present invention.

FIGS. 8A and 8B illustrate sectional views of the proximal and distalends of the patient access device of FIG. 7, consistent with aspects ofthe present invention.

FIG. 9A illustrates another embodiment of the patient access device ofFIGS. 1A-1C constructed with a wiper or brush within a lumen of thepatient access device to assist in preventing gas from exiting thedistal end of the lumen while a portion of an elongate probe is withinthe lumen, consistent with aspects of the present invention.

FIG. 9B illustrates another embodiment of the patient access device ofFIGS. 1A-1C constructed with a second fluid pathway intersecting thelumen which allows for a second current of water, or “water curtain” tobe flushed over the probe to assist in preventing gas from exiting thedistal end of the lumen while a portion of the probe is within thelumen, consistent with aspects of the present invention.

FIG. 9C illustrates another embodiment of the patient access device ofFIGS. 1A-1C constructed with an ultrasonic or other mechanical vibratorattached or coupled to the patient access device to assist in preventinggas from exiting the distal end of the lumen while a portion of anelongate probe is within the lumen, consistent with aspects of thepresent invention.

DETAILED DESCRIPTION

Embodiments of the invention will now be described with reference to thefigures, wherein like numerals reflect like elements throughout. Thepresent inventive concept may, however, be embodied in many differentforms and should not be construed as limited to the exemplaryembodiments set forth herein.

It will be understood that, although the terms first, second, etc. arebe used herein to describe various elements, these elements should notbe limited by these terms. These terms are used to distinguish oneelement from another, but not to imply a required sequence of elements.For example, a first element can be termed a second element, and,similarly, a second element can be termed a first element, withoutdeparting from the scope of the present invention. As used herein, theterm “and/or” includes any and all combinations of one or more of theassociated listed items.

It will be understood that when an element is referred to as being “on”or “connected” or “coupled” to another element, it can be directly on orconnected or coupled to the other element or intervening elements can bepresent. In contrast, when an element is referred to as being “directlyon” or “directly connected” or “directly coupled” to another element,there are no intervening elements present. Other words used to describethe relationship between elements should be interpreted in a likefashion (e.g., “between” versus “directly between,” “adjacent” versus“directly adjacent,” etc.).

As used herein, the singular forms “a,” “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises,”“comprising,” “includes” and/or “including,” when used herein, specifythe presence of stated features, steps, operations, elements, and/orcomponents, but do not preclude the presence or addition of one or moreother features, steps, operations, elements, components, and/or groupsthereof.

Spatially relative terms, such as “beneath,” “below,” “lower,” “above,”“upper” and the like may be used to describe an element and/or feature'srelationship to another element(s) and/or feature(s) as, for example,illustrated in the figures. It will be understood that the spatiallyrelative terms are intended to encompass different orientations of thedevice in use and/or operation in addition to the orientation depictedin the figures. For example, if the device in the figures is turnedover, elements described as “below” and/or “beneath” other elements orfeatures would then be oriented “above” the other elements or features.The device may be otherwise oriented (e.g., rotated 90 degrees or atother orientations) and the spatially relative descriptors used hereininterpreted accordingly.

The terminology used in the description presented herein is not intendedto be interpreted in any limited or restrictive way, simply because itis being utilized in conjunction with detailed description of certainspecific embodiments of the invention. Furthermore, embodiments of theinvention may include several novel features, no single one of which issolely responsible for its desirable attributes or which is essential topracticing the invention described herein. The words proximal and distalare applied herein to denote specific ends of components of theinstrument described herein. A proximal end refers to the end of aninstrument nearer to an operator of the instrument when the instrumentis being used and/or an end opposite the distal end. A distal end refersto the end of a component further from the operator and/or extendingtowards the surgical area of a patient and/or the implant.

For many diagnostic or therapeutic clinical procedures (e.g.percutaneous procedures), it is critical to prevent the introduction ofair or other gas into the patient (e.g. into the patient's vascularsystem) when an elongate probe, such as a catheter or other elongatemedical device, is inserted into the patient. The inserted elongateprobes or other medical devices can include but are not limited to:guidewires, balloon catheters, stent delivery catheters, ablationcatheters, neurovascular catheters, embolization catheters, and manyother types of insertable medical devices that can be used to diagnoseor treat a wide variety of diseases or disorders within the patient. Insome embodiments, an inserted elongate probe can include a complex shapeor non-tubular shape (e.g. on the distal end or a distal portion of theprobe) that is likely to trap air or other gas when introduced, such asa catheter with an expandable array distal portion. In some embodiments,the expandable array comprises an element selected from the groupconsisting of one or more of: a spiral array; a basket constructionarray; an array of transducers; an array of sensors and/or transducers;an array of electrodes; and/or combinations and/or sub-combinations ofthese.

In accordance with the present invention, there are provided an improveddevice, system and method for preventing or at least reducing air orother gas bubbles from entering a patient body lumen (e.g. a vein orartery of the patient's cardiovascular system) during a percutaneousprocedure by using a patient access device constructed and arranged toprevent or at least reduce gas from exiting a distal end of the patientaccess device, such as during advancement of an elongate medical deviceor other elongate probe (e.g. a catheter or other percutaneous device)into the patient's body lumen. In some embodiments, the patient accessdevice is constructed and arranged to evacuate air or other gas bubblesfrom the patient access device.

FIGS. 1A and 1B show one embodiment of a patient access device 100having a hollow shaft 102, a proximal end 106, a proximal portion 107, adistal end 108, a distal portion 109, and a lumen 104 extending fromproximal end 106 to distal end 108. In some embodiments, shaft 102passes fully through proximal portion 107 and distal portion 109 suchthat shaft 102 comprises lumen 104. In other embodiments, shaft 102terminates at or within a portion of portions 107 and/or 109, such thatlumen 104 extends beyond shaft 102 on either or both ends of shaft 102.In some embodiments, patient access device 100 is constructed andarranged to attach to or be inserted into a vascular introducer. Inother embodiments, distal portion 109 comprises or forms a conduit (e.g.a distal portion of shaft 102), through which lumen 104 fluidlycontinues, that is constructed and arranged to be percutaneouslyinserted into the patient's vascular system, avoiding the need for aseparate vascular introducer. Proximal portion 107 includes an inputport 110 and a valve assembly 112 configured to restrict fluid flowbetween lumen 104 and an inserted elongate probe, such as a catheter(see FIG. 3B). Distal portion 109 includes an output port 114 for theelongate probe to exit toward a patient's body lumen and a valveassembly 116 configured to restrict fluid flow between lumen 104 and anintroducer (e.g. a vascular introducer) and/or the patient's body lumen.In some embodiments, proximal and distal valve assemblies 112, 116 canbe the same, in other embodiments, they can be different, such as whenone valve assembly is configured as a higher pressure valve than theother. For example, proximal valve assembly 112 can be configured toallow a flow at a first pressure and distal valve assembly 116 can beconfigured to allow flow at a second, different pressure. The secondpressure can be higher than the first (i.e. distal valve assembly 116allows flow at a higher pressure than proximal valve assembly 112), orthe first pressure can be higher than the second (i.e. distal valveassembly 116 allows flow at a lower pressure than proximal valveassembly 112).

Patient access device 100 further includes a liquid supply port in fluidcommunication with lumen 104. The liquid supply port can include a luerconnector. In the embodiment shown in FIGS. 1A and 1B, the liquid supplyport includes liquid supply shaft 118 with a lumen having a proximalport 120 and a distal port 122. The liquid supply shaft 118 can be aflexible tube. The proximal port 120 is configured to couple to andreceive fluid from a fluid source, and the distal port 122 is in fluidcommunication with lumen 104. Proximal port 120 can include a luerconnector fluidly attached to the fluid source. Liquid supply shaft 118further includes a control 124 to initiate or regulate the fluid flowfrom the fluid source to lumen 104. Control 124 can include: a stopcock,a roller valve, a button, or other suitable valve. Control 124 can bemanually operated (e.g. operator initiated), or electronically operated(e.g. automatically or electronically initiated, see also FIG. 4), orsome combination thereof. Control 124 can perform multiple functions,such as initiate flow of fluid; increase or decrease rate of flow offluid; set the volume of the flow of fluid; and combinations of these.In FIG. 1A control 124 comprises a valve in the closed position and inFIG. 1B the valve is in the open position.

Distal port 122 of liquid supply shaft 118 can be coupled at any pointalong lumen 104 between the proximal and distal ends 106, 108. In theembodiment shown in FIGS. 1A and 1B, the liquid supply shaft 118 is atthe proximal portion 107, close to the valve assembly 112. In anotherembodiment shown in FIG. 1C, the patient access device 100′ can includethe liquid supply shaft 118 near distal portion 109 and valve assembly116.

The patient access device 100, 100′ is constructed and arranged toprevent air or other gas within lumen 104 from exiting distal end 108while a portion of an elongate medical device or other elongate probe isadvanced or otherwise disposed within lumen 104, so that gas does notenter into the patient's vascular system or other body lumen. Air orother gas can inadvertently enter the vasculature for a number ofreasons. In some instances, gas from the external environment (e.g. airin a clinical procedure room environment) is drawn into a vascularintroducer while a probe is advanced through the introducer. Duringadvancement of the probe, a pressure differential can be created due tothe elongate probe acting as a fully or partially sealing plug, similarto a piston in a cylinder, reducing pressure within the lumen of theintroducer as the probe is inserted and “pulling” air through theroom-exposed, proximal end of the introducer. Alternatively, gas canpass from the external environment through a valved proximal portion ofan introducer when the valve is deformed or otherwise damaged, such asdamage caused during the passage of multiple elongate probes into andout of the valve, such as when multiple probes are used in a singleclinical procedure. Air or other gas bubbles can also enter anintroducer lumen as they cling to an inserted probe, such as gas bubblesthat become attached due to surface tension and/or the device geometryor shape. The trapped gas bubbles can enter the vasculature along withthe inserted probe if not removed by the patient access device.

Patient access device 100 can be constructed of an individualbiocompatible material or a combination or sub-combination of two ormore biocompatible materials selected from the group consisting of:metal, such as stainless steel, cobalt alloys, Ni—Ti alloys or titaniumalloys; ceramic; plastic; polymers, such as polyethylene,polyvinylchloride, polyurethane or polylactide; flexible materials, suchas silicone or latex; and/or combinations and/or sub-combinations ofthese.

In some embodiments, shaft 102 can include a rigid or semi-rigidtransparent material. In other embodiments, one or more portions ofshaft 102 can comprise a transparent compliant material, such that theuser can manually compress shaft 102 to propel any gas bubbles (e.g.visible gas bubbles) within shaft 102, such as to exit proximal portion107. This compliant material could be supported by a support elementsuch as a Nitinol coil, or columns, which would provide scaffoldingradial support, but still allow for manual manipulation of the medicaldevice or probe within the shaft 102.

FIGS. 2A-2C illustrate one embodiment of shaft 102 comprising multiplesections, a proximal portion 102 a, a compression portion 102 b and adistal portion 102 c. Shaft 102 can be any length so that it can be usedwith medical devices or probes of differing lengths. In someembodiments, shaft 102 can have a length between about 1 and about 6inches, as an example. Proximal portion 102 a and distal portion 102 ccan be made of a transparent tube of semi-rigid to rigid material. Thecompression portion 102 b can be made of a low durometer tube capable ofcompression at low force. The compression portion 102 b can be used withother pieces to make distal valve assembly 116 of FIGS. 1A-1C. FIG. 2Bshows an O-ring 126 placed on compression portion 102 b, for example, ina saddle or indented section of compression portion 102 b. Othercomponents, such as a compressible collar 128, can be added, shown inFIG. 2C over the compression portion 102 b and the O-ring 126 to createa valve, distal valve assembly 116 as shown, for example, a Tuohy Borstvalve. While this embodiment shows only one compression portion 102 bshown on the shaft 102, it is understood that more than one compressionportion 102 b can be positioned along shaft 102 forming multiple valves,for example, this arrangement can also be used to form the proximalvalve 112 of FIGS. 1A-1C.

FIGS. 3A-3D illustrate one embodiment of the patient access device 100with an elongate medical device or other elongate probe having afunctional segment 146 and a shaft portion 148. Various methods of usingthe elongate medical device or other elongate probe with the patientaccess device 100, e.g., diagnostic or therapeutic methods, may bereadily understood by those skilled in the art based on this disclosure.

In some embodiments, functional segment 146 can comprise an expandableelement, such as an array of sensors or transducers mounted to anexpandable basket or other structure that may tend toward capturing airbubbles during insertion. Functional segment 146 can be constructed andarranged to perform a diagnostic or therapeutic event or function in aclinical procedure. In some embodiments, the diagnostic event orfunction comprises recording electrical signals or ultrasound signals,such as when functional segment 146 comprises an array of sensorspositioned in a chamber of a heart. In some embodiments, the therapeuticevent or function comprises delivering energy to cardiac tissue, such aswhen functional segment 146 comprises an array of electrodes configuredto deliver radiofrequency energy to tissue. Functional segment 146 isinserted into input port 110 at proximal end 106, with valve assembly112 in the open position (FIG. 3A). Functional segment 146 is thenpositioned within lumen 104. Valve assembly 112 is then closed aroundshaft portion 148 and sealed (FIG. 3B). At this point, all that is inlumen 104 is functional segment 146, some of the shaft portion 148 andpotentially one or more air or other gas bubbles. Water or fluid 150,for example sterile saline, is then introduced into lumen 104 via liquidsupply shaft 118. For example, fluid 150 can be in a syringe, IV bag orfluid pump coupled to proximal port 120. As fluid 150 continues to filllumen 104, gas bubbles 152 can form (FIG. 3C). In one embodiment, toremove the bubbles 152, the proximal valve 112 and/or the distal valve116 can be slightly opened to allow some of fluid 150 to seep out 154.In another embodiment, to remove the bubbles 152, one valve assembly canbe configured at a higher pressure than the other valve, and the lowerpressure valve assembly can allow some of the fluid 150 to seep out 154,while the higher pressure valve assembly does not. By having transparentsides on shaft 102, this procedure can be viewed and manually continueduntil the bubbles 152 are gone (FIG. 3D).

If the patient access device 100 is being used during a percutaneousprocedure and the elongate medical device or other elongate probe needsto be changed, the steps described hereabove can be modified. In thisembodiment, the patient access device 100 is constructed and arranged toprevent air or other gas bubbles from passing from the distal end 108and into the patient's body lumen, as the elongate probe is advancedthrough lumen 104. For example, when the first probe is in use, distalvalve 116 will be attached or be part of an introducer (e.g. a vascularintroducer). For an exchange of elongate probes, the first probe ispulled back into lumen 104 and distal valve 116 is closed, to preventblood from entering lumen 104 and/or to prevent gas bubbles from lumen104 entering the patient's body lumen. The first probe is then removedthrough proximal valve 112. The second probe is then inserted into lumen104. Since it is in use, there can already be some fluids, such asblood, within lumen 104 along with one or more gas bubbles. Oncefunctional segment 146 and some of shaft portion 148 are inside lumen104, valve assembly 112 is then closed around shaft portion 148 andsealed. Fluid 150 is then introduced into lumen 104 via liquid supplyshaft 118 (like in FIG. 3C). To remove any gas bubbles 152, proximalvalve 112 can be slightly opened to allow some of fluid 150 and blood toseep out 154. By having transparent sides on shaft 102, this procedurecan be viewed and manually continued until bubbles 152 are gone. Oncethe gas bubbles are gone, distal valve 116 can be opened and functionalsegment 146 can continue advancement, through the introducer and intothe patient's body lumen. In some embodiments, distal valve assembly 116can be a valve assembly constructed and arranged at a sufficiently highpressure to prevent fluid leakage or seepage during use, and theproximal valve assembly 112 can be a valve assembly constructed andarranged at a sufficiently low pressure to allow fluid leakage orseepage during use.

FIG. 4 shows one embodiment of a “smart” patient access device 100″,similar to patient access device 100, but including additionalcomponents to increase its capability. For example, patient accessdevice 100″ can include one or more of the following: a detection sensor130, a flow sensor 132, a bubble detector 134, a battery 136 and analarm transducer 138. These additional components can allow for moreautomation of the insertion or exchange procedures of the probe into thepatient's body lumen. Additionally, the additional components canincrease the safety aspects of the patient access device. In someembodiments, the detection sensor 130 can be used to detect insertion ofa probe's functional segment 146 (not shown, but such as functionalsegment 146 described hereabove) into input port 110 and/or lumen 104.The detection sensor 130 can also be connected to an electronicallyoperated control 124 on the fluid delivery system to automaticallydeliver fluid based on one or more signals produced by sensor 130, suchas detection of an elongate probe inserted into input port 110 and/orlumen 104. In some embodiments, flow sensor 132 is designed to produce asignal based on the fluid flow through lumen 104. The signal can be usedto maintain fluid flow above a certain flow rate, for example, above 1ml/min. In some embodiments, flow sensor 132 is configured to produce asignal corresponding to the flow rate or volume of fluid flowing throughthe lumen 104. In some embodiments, bubble detector 134 is configured todetect gas bubbles in lumen 104. Bubble detector 134 can be placed atany desired location lumen 104, for example, in and/or proximate todistal portion 109, or in and/or proximate to shaft 102. In someembodiments, bubble detector 134 can be an ultrasound bubble detector.The components can require power, so in some embodiments a power supplycan be provided, such as battery 136. In some embodiments, alarmtransducer 138 can be used, for example, an audio or tactile transducer,to activate an alarm when one or more conditions are detected. The alarmconditions that can be detected include, but are not limited to, one ormore of the following: absence of flow; flow rate below a threshold;presence of a gas bubble; advancement of elongate probe; andcombinations of these.

FIG. 5 shows the patient access device 100, 100′ or 100″ (generally 100)in use with an elongate medical device or other elongate probe for apercutaneous procedure. In the embodiment shown, an introducer 140 hasbeen inserted through the patient's skin 142 accessing the patient'sbody lumen 144. The distal end of introducer 140 is positioned withinthe patient's body lumen 144 while the proximal end is coupled to distalend 108 of the patient access device. In some embodiments, theintroducer 140 is a separate component, while in other embodiments, theintroducer 140 is an extension or part of the distal end 108 of patientaccess device 100. Patient access device 100 is constructed and arrangedto prevent gas bubbles from passing from the distal end 108 into apatient's body lumen 144 as an elongate probe is advanced through lumen104. Functional segment 146 is inserted into input port 110 andpositioned within lumen 104. Valve assembly 112 is then closed aroundshaft portion 148 and sealed. Water or fluid 150, for example sterilesaline, from a fluid delivery system 151 is then introduced into lumen104 via liquid supply shaft 118 having control 124. For example, fluiddelivery system 151 can be a syringe, IV bag or fluid pump, such as aperistaltic pump or other suitable pump. As fluid 150 continues to filllumen 104, gas bubbles 152 can form (see FIG. 3C). In one embodiment, toremove bubbles 152, proximal valve assembly 112 can be slightly openedto allow some of fluid 150 to seep out 154 (see FIG. 3C). In anotherembodiment, distal valve assembly 116 can be a higher pressure valvethan proximal valve assembly 112, such that proximal valve assembly 112allows some of the fluid 150 to seep out 154 to remove bubbles 152,while the higher pressure distal valve assembly 116 does not allow fluidto pass. By having transparent sides on shaft 102, this procedure can beviewed and manually continued until bubbles 152 are gone. Once bubbles152 are viewed to be removed, distal valve assembly 116 can be openedand functional segment 146 can be inserted through introducer 140 andinto the patient's body lumen 144, such as for subsequent diagnosisand/or treatment.

If the patient access device is the “smart” patient access device 100″additional steps can be performed. For example, detection sensor 130 candetect insertion of a probe's functional segment 146 into input port 110and/or within lumen 104, such as to then send signals to theelectronically operated control 124 on the fluid delivery system toautomatically deliver fluid to the lumen 104 of the shaft 102. Flowsensor 132 can produce a signal based on the fluid flow through lumen104. The signal can include detection of the rate of fluid flow throughlumen 104. Bubble detector 134 can be used to detect one or more gasbubbles in lumen 104. The components can be powered by battery 136.Alarm transducer 138 can emit an alarm when one or more conditions aredetected, such as: absence of flow; flow rate below a threshold;presence of a gas bubble; advancement of elongate probe; andcombinations of these.

Sometimes, the elongate medical device or other elongate probe can needto be exchanged during a procedure for another probe. For an exchange,the first probe can be pulled back from the patient's body lumen 144through the introducer 140 and into lumen 104. The distal valve 116 canthen be closed to prevent blood from entering lumen 104 and/or preventgas bubbles from lumen 104 entering the patient's body lumen 144. Thefirst probe can then be removed through proximal valve 112. The secondprobe can then be inserted into lumen 104 and proximal valve 112 can beclosed. Since it is in use, there can already be some fluids, such asblood, within lumen 104 along with one or more gas bubbles. Oncefunctional segment 146 and some of shaft portion 148 of the second probeis inside lumen 104, valve assembly 112 can then be closed around shaftportion 148 and sealed, and fluid 150 can then be introduced into lumen104 via liquid supply shaft 118. At this point, the rest of theprocedure is the same as described hereabove to remove bubbles 152 andonce bubbles are absent, distal valve assembly 116 can be opened andfunctional segment 146 of the second probe can be inserted throughintroducer 140 and into the patient's body lumen 144, such as forsubsequent diagnosis and/or treatment.

FIGS. 6A and 6B show other embodiments of a patient access device 200having a hollow shaft 202, a proximal end 206, a proximal portion 207, adistal portion 209, a distal end 208, and a lumen 204 extending fromproximal end 206 to distal end 208. The proximal portion 207 includes aninput port 210 and valve assembly 212 configured to restrict flowbetween lumen 204 and an inserted elongate probe, such as a catheter orother percutaneous device. Distal portion 209 includes an output port214 for the elongate probe to exit toward a patient's body lumen andvalve assembly 216 configured to restrict fluid flow between lumen 204and patient's body lumen. In some embodiments, the proximal and distalvalve assemblies 212, 216 can be the same, in other embodiments, theycan be different, such as one valve assembly can constructed andarranged to operate at a higher pressure than the other valve assembly.For example, proximal valve assembly 212 can allow a flow at a firstpressure and the distal valve assembly 216 can allow flow at a second,different pressure. The second pressure can be higher than the first(i.e. distal valve assembly 216 allows flow at a higher pressure thanproximal valve assembly 212), or the first pressure can be higher thanthe second (i.e. distal valve assembly 216 allows flow at a lowerpressure than proximal valve assembly 212).

Patient access device 200 further includes a liquid supply input port218 a and a liquid supply output port 218 b in fluid communication withlumen 204. The liquid supply input and output ports, 218 a and 218 b caninclude luer connectors. The liquid supply input port 218 a isconfigured to couple and receive fluid from a fluid source and deliverfluid to lumen 204. The liquid supply output port 218 b is configured toallow fluid to exit from lumen 204. The liquid supply output port 218 bcan also include a check valve or one way valve 224 b that allows fluidto only flow out of lumen 204 and does not let air or other gas intolumen 204. The liquid supply input port 218 a can further include acontrol 224 a, such as described hereabove for control 124, to initiateor regulate the fluid flow from the fluid source to lumen 204. Control224 a can include a stopcock, a roller valve or a button. Control 224 acan be manually operated (e.g. operator initiated), or electronicallyoperated (e.g. automatically start the fluid flow). Control 224 a canperform multiple functions, such as initiate flow of fluid; increase ordecrease rate of flow of fluid; set the volume of the flow of fluid; andcombinations thereof. The patient access device 200 can also include“smart” patient access device features, such as described hereabove for“smart” patient access device 100″, having one or more of the following:a detection sensor 130, a flow sensor 132, a bubble detector 134, abattery 136 and an alarm transducer 138.

FIG. 6A shows a patient access device 200 that comprises an “open” fluidsystem that does not recirculate fluid 250 during use. A fluid source,such as a syringe, IV bag or fluid pump, is coupled to liquid supplyinput port 218 a. Fluid 250 enters liquid supply input port 218 a viacontrol means 224 a, flows through lumen 204 and exits liquid supplyoutput port 218 b through check valve or one way valve 224 b.

FIG. 6B shows a patient access device 200 that comprises a “closed”fluid system that is configured to recirculate fluid 250 during use.Fluid 250 is stored in a recirculating fluid delivery system 251 thatincludes a fluid pumping means. Recirculating fluid delivery system 251is coupled to both liquid supply input port 218 a and liquid supplyoutput port 218 b. Fluid 250 enters the liquid supply input port 218 avia control means 224 a, flows through lumen 204 and exits liquid supplyoutput port 218 b through one way valve 224 b and returns torecirculating fluid delivery system 251. Within recirculating fluiddelivery system 251, gas bubbles are extracted or percolate from thefluid 250 and then the fluid is used again.

FIGS. 7, 8A and 8B show another embodiment of a patient access device300 having a shaft 302, a proximal end 306, a proximal portion 307, adistal portion 309, a distal end 308, and a lumen 304 extending fromproximal end 306 to distal end 308. The proximal portion 307 includes aninput port 310 and funnel shaped assembly 312 configured to receive adistal portion of an elongate probe, such as a catheter or otherpercutaneous device. Funnel shaped assembly 312 can also be configuredto radially compact an expanded portion of the elongate probe duringinsertion. Distal portion 309 includes an output port 314 for theelongate probe to exit toward a patient's body lumen and valve assembly316 configured to restrict fluid flow 354 (see FIGS. 8A and 8B) betweenlumen 304 and the patient's body lumen. Shaft 302 includes at least onefluid delivery tube 350. Fluid delivery tubes 350 can be within the wallof shaft 302 and/or positioned within lumen 304, for example, proximallumen 304 wall of shaft 302. Fluid delivery tubes 350 can extend alongshaft 302 for any length desired, for example, fluid delivery tubes 350can extend from the proximal portion 307 to distal portion 309. In someembodiments, there are multiple fluid delivery tubes 350. Each of thefluid delivery tubes 350 includes at least one outlet port 352 in fluidcommunication with lumen 304. In the embodiment shown, fluid deliverytubes 350 are coupled with funnel shaped assembly 312 (see FIG. 8A).

Patient access device 300 further includes a liquid supply port 318 influid communication with lumen 304 via fluid delivery tubes 350 andoutlet ports 352. In the embodiment shown, shaft 302 liquid supply port318 is coupled with funnel shaped assembly 312 (see FIG. 8A). Liquidsupply input port 318 is configured to couple and receive fluid from afluid source and deliver fluid to lumen 304 via fluid delivery tubes 350and outlet ports 352. Liquid supply input port 318 can further include acontrol 324, such as is described hereabove for control 124, to initiateor regulate the fluid flow 354 from the fluid source to lumen 304.Control 324 can include a stopcock, a roller valve or a button. Control324 can be manually operated (e.g. operator initiated), orelectronically operated (e.g. automatically start the fluid flow 354).Control 324 can perform multiple functions, such as: initiate flow offluid; increase or decrease rate of flow of fluid; set the volume of theflow of fluid; and combinations thereof. Patient access device 300 canalso include “smart” patient access device features, such as describedhereabove for “smart” patient access device 100″, having one or more ofthe following: a detection sensor 130, a flow sensor 132, a bubbledetector 134, a battery 136 and an alarm transducer 138.

FIGS. 9A-9C show additional features that can be added to any of thepatient access devices discussed above. While these features are shownwith regard to patient access device 100, they also can be part ofpatient access device 100′, 100″, 200 or 300. FIG. 9A shows anembodiment of the patient access device having a gas disruptingcomponent 402, such as a wiper or brush, positioned within lumen 104 andconstructed and arranged to disrupt gas bubbles as the elongate medicaldevice or other elongate probe functional segment 146 is insertedthrough shaft 102. Gas disrupting component 402 can comprise smallfibers or other material to brush and disrupt air bubbles as the probepasses gas disrupting component 402. FIG. 9B shows an embodiment havinga second fluid pathway 404 intersecting lumen 104 which allows for asecond current of water, or “water curtain” 406 to be flushed overfunctional segment 146 as it passes, similar to the air blow dryers at acar wash. The second fluid pathway can be manually fed with fluid, suchas with a syringe, or automatically fed with fluid via a pump or othermeans (not shown). The fluid in the second fluid can be the same or canbe a different fluid than the first fluid flowing through the shaftlumen. FIG. 9C shows one embodiment of a vibrating element 408, such asan ultrasonic or other mechanical vibrator, attached or coupled to theshaft 102. Vibrating element 408 is configured to vibrate shaft 102 andphysically disrupt gas bubbles within lumen 104 and/or on functionalsegment 146.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theembodiments disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims. In addition,where this application has listed the steps of a method or procedure ina specific order, it may be possible, or even expedient in certaincircumstances, to change the order in which some steps are performed,and it is intended that the particular steps of the method or procedureclaims set forth herebelow not be construed as being order-specificunless such order specificity is expressly stated in the claim.

1. A patient access device comprising: a hollow shaft comprising aproximal end, a distal end, and a lumen therethrough; an input portcoupled to the proximal end configured to receive an elongated probe,the input port comprising a first valve assembly configured to allowfluid flow at a first pressure; an output port coupled to the distal endcomprising a second valve assembly configured to allow fluid flow at asecond pressure; and a liquid supply port in fluid communication withthe lumen of the shaft configured to deliver fluid to the lumen; whereinthe patient access device is configured to flush fluid over at least aportion of the elongated probe positioned in the lumen at a pressurewithin the shaft, between the first pressure and second pressure, anddrive a gas introduced into the shaft to exit the shaft lumen via thefirst and/or second valve assembly. 2-97. (canceled)
 98. The patientaccess device of claim 1, wherein the second pressure is higher than thefirst pressure such that the fluid at least one of leaks or seepsthrough the first valve assembly.
 99. The patient access device of claim1, wherein the first pressure is higher than the second pressure suchthat the fluid at least one of leaks or seeps through the second valveassembly.
 100. The patient access device of claim 1, further comprisinga fluid delivery assembly connected to the input port and configured todeliver fluid to the lumen of the shaft.
 101. The patient access deviceof claim 100, wherein the fluid delivery assembly includes a sensorconfigured to detect insertion of the elongated probe into the inputport and the fluid delivery assembly is further configured toautomatically deliver fluid based on one or more signals produced by thesensor.
 102. The patient access device of claim 100, wherein the fluiddelivery assembly includes one or more controls configured to allow anoperator to perform a function selected from the group consisting of:initiate flow of fluid; increase or decrease rate of flow of fluid; setthe magnitude of the flow of fluid; and/or combinations thereof. 103.The patient access device of claim 1, wherein a portion of the shaft istransparent.
 104. The patient access device of claim 103, wherein thetransparent portion is made of a compliant material having a supportelement configured to enable a user to manually massage out any visibleair bubbles within the shaft.
 105. The patient access device of claim 1,wherein the patient access device is constructed of one or morebiocompatible materials selected from the group consisting of: metal;stainless steel; a cobalt alloy; a nickel titanium alloy, a titaniumalloy; ceramic; plastic; a polymer; polyethylene; polyvinylchloride;polyurethane; a polylactide; silicone; latex; and/or combinationsthereof.
 106. The patient access device of claim 1, further comprisingone or more sensors.
 107. The patient access device of claim 106, wherethe one or more sensors include a detection sensor configured to detectinsertion of the elongated probe into the input port and/or the hollowshaft.
 108. The patient access device of claim 106, where the one ormore sensors include a flow sensor configured to detect a fluid flowthrough the lumen.
 109. The patient access device of claim 106, wherethe one or more sensors include a gas bubble detector configured todetect a gas bubble in the lumen of the shaft.
 110. The patient accessdevice of claim 1, further comprising a vibrating element configured tovibrate the shaft and physically disrupt gas bubbles within lumen. 111.The patient access device of claim 1, further comprising an alarmtransducer configured to activate an alarm when a condition is detected,wherein said condition is selected from the group consisting of: absenceof flow; flow rate below a threshold; presence of a gas bubble;advancement of elongated probe; and/or combinations thereof.
 112. Thepatient access device of claim 1, wherein the elongated probe selectedfrom the group consisting of: guidewires; balloon catheters; stentdelivery catheters; ablation catheters; neurovascular catheters;embolization catheters; and/or other insertable medical devices used todiagnose or treat a wide variety of diseases or disorders.
 113. Thepatient access device of claim 1, wherein the elongated probe comprisesan expandable array selected from the group consisting of: a spiralarray; a basket construction array; an array of transducers; an array ofsensors and/or transducers; an array of electrodes; and/or combinationsand/or sub-combinations of these.
 114. The patient access device ofclaim 1, wherein the valve assembly comprises a Tuohy-borst valveassembly.
 115. The patient access device of claim 1, further comprisinga fluid output port in fluid communication with the lumen of the shaft.116. The patient access device of claim 115, wherein the shaft comprisesa proximal portion and a distal portion, and wherein the fluid inputport is in fluid communication with the shaft proximal portion and thefluid output port is in fluid communication with the shaft distalportion.